PROJECT SUMMARY Biopsy capability is an absolute requirement for imaging facilities planning to provide breast cancer screening services. The limitations of mammography have ushered in several other imaging technologies, such as magnetic resonance (MR), positron emission mammography, and breast specific gamma, or molecular breast imaging. However, these are all relatively expensive modalities and require contrast injection, limiting their potential use for screening of the general population. We therefore developed a more quantitative and less expensive approach for evaluation of breast masses using the principles of ultrasound tomography (UST). Our new commercial UST scanner, named SoftVue (Delphinus Medical Technologies), now has sufficient resolution, contrast and speed to address the burden of screening of the general population, but a biopsy solution using 3-D UST data is still needed. Our goal is the development of a convenient, out-of-water biopsy solution for UST detected masses, which then also serves as operator independent biopsy option for the gamut of breast biopsies. The objective of this Phase I application, and the next step in pursuit of that goal, is to validate a UST-based biopsy concept for further development. With the feasibility of our new UST unit established by our extensive prior and current work, the rationale for the proposed study is that a cost-effective UST-based biopsy solution will lead to much broader commercialization of a practical, low-cost device that supports breast cancer screening and diagnosis with major societal impact for most breast biopsies. We propose to test the SoftVue biopsy system in the lab (Phase I), and then in the clinic (future Phase II application) to validate its performance and readiness for the marketplace. Building on our supportive preliminary data, we have assembled a multidisciplinary research team with the scope and breadth of expertise needed to successfully carry out the proposed work under optimal clinical and engineering environments. Delphinus Medical Technologies Inc provides a deep pool of clinical and engineering expertise with UST, while the G.E. engineering team has extensive development experience with biopsy systems.